INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE

K972842 · Interpore Intl. · LYC · Oct 30, 1997 · Dental

Device Facts

• Record ID: K972842
• Device Name: INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
• Applicant: Interpore Intl.
• Product Code: LYC · Dental
• Decision Date: Oct 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2

Intended Use

The Interpore Inducer Bone Graft Delivery Syringe is indicated for the delivery of allograft, autograft or synthetic bone graft material to an orthopaedic surgical site. In addition, it is designed to facilitate pre-mixing of a bone graft material with I.V. fluids, blood, plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. The Interpore Inducer has a volume of approximately 15 cc.

Device Story

The Interpore Inducer is a 15cc piston syringe used by surgeons in orthopaedic procedures to deliver bone graft materials (allograft, autograft, or synthetic) to surgical sites. The device features a barrel, piston, plunger, and a removable distal top cap with a male luer-lok connector. It allows for the pre-mixing of graft materials with fluids, blood, or bone marrow via luer-lok connections. The surgeon loads the graft material into the barrel, attaches the plunger, and manually expels the contents into the operative site. The device is supplied sterile for single use. It provides a controlled method for graft delivery, reducing potential contamination and facilitating the preparation of graft mixtures at the point of care.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Piston syringe design; 15cc volume; includes syringe barrel, top cap, piston, and plunger; features male and female luer-lok connectors for fluid transfer; supplied sterile in double aseptic packaging; single-use.

Indications for Use

Indicated for delivery of allograft, autograft, or synthetic bone graft materials to orthopaedic surgical sites. Facilitates pre-mixing of graft materials with I.V. fluids, blood, plasma, or bone marrow. Restricted to prescription use by licensed physicians.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Interpore 200 Coralline Hydroxyapatite Syringe Delivery System (K841201)
• Grafton Allogeneic Bone Matrix Syringe

Submission Summary (Full Text)

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510(k) Premarket Notification Interpore Inducer Bone Graft Delivery Syringe

Interpore International - Confidential -

OCT 3 0 1997

K972842

### APPENDIX IV

## 510(k) SUMMARY

### FOR

# THE INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE

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#### 510(k) SUMMARY

#### SUBMITTED BY:

David P. Balding Director, Quality Assurance and Regulatory Affairs Interpore International 181 Technology Drive Irvine, California 92618 Telephone: [phone] Facsimile: 714-453-3225

July 31, 1997 Date Submitted:

#### CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME:

Classification Name: Common/Usual Name: Proprietary Name:

Piston Syringe Bone Graft Delivery Syringe Interpore Inducer Bone Graft Delivery Syringe

#### PREDICATE DEVICES

Interpore 200 Coralline Hydroxyapatite Syringe Delivery System [reference 510(k) K841201 cleared 8/3/84] and the Grafton Allogeneic Bone Matrix Syringe dental LYC

#### DEVICE DESCRIPTION

The INTERPORE Inducer Bone Graft Delivery Syringe is a piston syringe intended for use to deliver allograft, autograft or synthetic bone graft materials to an orthopaedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. The Interpore Inducer has a volume of approximately 15cc.

The Interpore Inducer is a specially designed syringe specifically intended to deliver bone graft materials to a surgical site. It is supplied sterile in double aseptic transfer packaging.

The Interpore Inducer consists of a syringe barrel, syringe top cap, piston and plunger. The distal end of the syringe has a removable top cap which must be aseptically removed in order to load the bone graft material into the syringe. After loading the syringe, the top cap may be reattached to the syringe to constrain the contents of the syringe or to minimize potential

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contamination of the syringe contents. In addition, the top cap has a male luer-lok connector which may be attached to any standard female luer adapter for fluid transfer.

The piston of the syringe is designed to eject fluids or blood components and bone graft materials into the operative site. It is also designed to be the attachment point for the syringe plunger. The proximal end of the piston also has a female luer-lok connector which may be connected to any standard male luer adapter for delivery of fluids or blood components into the syringe.

The syringe plunger is provided separately and is attached to the proximal end of the syringe piston immediately prior to bone graft expulsion from the syringe into the surgical site.

#### PRODUCT INTSTRUCTIONS FOR USE ASEPTIC TECHNIQUE REQUIRED

- Open outer package and, if desired, deliver sterile inner package onto a 1. sterile field.
- 2. Open inner package.
- Remove syringe barrel. Note that the syringe piston is already 3. withdrawn. The volume of the syringe, when filled, is approximately 15cc.
- Firmly grasp the syringe barrel with one hand and with the other র . hand rotate the top cap in a counter-clockwise direction.
- Remove the top cap. Do not remove the luer cap. 5.
- Holding the syringe barrel upright, fill the syringe with the desired 6. amount of bone graft material. If necessary, pack the material into the syringe removing as much air as practical.
- Replace the top cap on the syringe barrel and rotate it in a clockwise 7. direction to lock the cap in place.
- If desired, add fluids to the graft material in the syringe by attaching a 8. fluid delivery device to the female luer-lok located at the proximal end of the piston.
- To flush fluids through the syringe, orient the syringe so that the top 9. cap is below the piston. The vented male luer protector need not be removed for flushing.
- To fill the syringe with fluid, hold the syringe with the top cap in the 10. UP direction while filling the syringe through the syringe piston (i.e, fill from the bottom of the syringe). Disconnect fluid source when filling or flushing is complete.
- Attach the syringe plunger handle to the female luer connector on the 11. proximal end of the syringe piston. Firmly turn the plunger handle in a clockwise direction to tighten. Caution: Do not over-tighten.
- For delivery of the graft material to a surgical site, remove the top cap 12. and discard.
- 13. Gently expel syringe contents into the desired graft location. Discard the syringe after use.

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#### WARNINGS

- This product is not intended for fluid injection into the circulatory . svstem.
- Blood or blood products may require the use of an anti-coagulent prior to use.
- This product is for single use only. Do not resterilize.
- . The Interpore Inducer is supplied sterile in individual double aseptic packages. The package should be inspected prior to use to ensure the sterility barrier has not been compromised.

Caution: Federal (USA) law restricts the use of this device to sale by or on the order of a licensed physician.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The product design, material of construction, and function as a piston syringe is substantially equivalent to the FDA cleared predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 1997

Mr. David P. Baldinq Director, Quality Assurance and Regulatory Affairs Interpore International 181 Technology Drive Irvine, California 92618-2402

Re : K972842 Trade Name: Interpore Inducer Bone Graft Delivery Svringe Requlatory Class: Unclassified Product Code: LYC Dated: July 31, 1997 Received: Auqust 1, 1997

Dear Mr. Balding:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you miqht have under sections 531

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Page 2 - Mr. Balding

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to beqin marketing your device as described in your 510 k) premarket notification. The-FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours;

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. ... ...

, Enclosure

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Interpore International - Confidential -

Page 1 of 1

#### 510(k) Number (if known): Not Known

Device Name: Interpore Inducer Bone Graft Delivery Syringe

#### Indications for Use:

The Interpore Inducer Bone Graft Delivery Syringe is indicated for the delivery of allograft, autograft or synthetic bone graft material to an orthopaedic surgical site. In addition, it is designed to facilitate pre-mixing of a bone graft material with I.V. fluids, blood, plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

The Interpore Inducer has a volume of approximately 15 cc.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Pamela D. Scatt
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number C972842

Prescription Use (PER 21 CFR 801.109)

OR

#### Over-The-Counter Use

(Optional Format 1-2-96)